estrogen/androgen combination Oral, Parenteral

Class Name: estrogen/androgen combination (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Covaryx


• Covaryx HS


• Essian


• Estratest


• Menogen


• Syntest D.S.


• Syntest H.S.

Available Dosage Forms:

• Tablet

Uses For This Medicine

Androgens and estrogens are hormones. Estrogens are produced by the body in greater amounts in females. They are necessary for normal sexual development of the female and for regulation of the menstrual cycle during the childbearing years. Androgens are produced by the body in greater amounts in males. However, androgens are also present in females in small amounts.

The ovaries and adrenal glands begin to produce less of these hormones after menopause. This combination product is prescribed to make up for this lower production of hormones. This may relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Androgens and estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens (contained in this combination medicine) will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during the menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes.

A paper called “Information for the Patient” should be given to you with your prescription. Read this carefully. Also, before you use an androgen and estrogen product, you and your doctor should discuss the good that it will do as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older women than it does in younger females.

Pregnancy

Estrogens (contained in this combination medicine) are not recommended for use during pregnancy, since some estrogens have been shown to cause serious birth defects in humans. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina and/or uterine cervix when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.

Androgens (contained in this combination medicine) should not be used during pregnancy because they may cause male-like changes in a female baby.

Breast Feeding

Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known. It is not known if androgens pass into breast milk. However, androgens may cause unwanted effects in nursing babies such as too early sexual development in males or male-like changes in females.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anisindione


• Bupropion


• Dicumarol


• Isotretinoin


• Phenprocoumon


• Theophylline


• Tizanidine


• Tranexamic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots (or history of during previous estrogen therapy)—Estrogens may worsen blood clots or cause new clots to form

• Breast cancer (active or suspected)—Estrogens may cause growth of the tumor

• Changes in vaginal bleeding of unknown causes—Some irregular vaginal bleeding is a sign that the lining of the uterus is growing too much or is a sign of cancer of the uterus lining; estrogens may make these conditions worse.

• Type 2 diabetes mellitus—Androgens can decrease blood sugar levels.

• Edema (swelling of feet or lower legs caused by retaining [keeping] too much body water) or


• Heart or circulation disease or


• Kidney disease or


• Liver disease—Androgens can worsen these conditions because androgens cause the body to retain extra fluid (keep too much body water). Also, heart or circulation disease can be worsened by androgens because androgens may increase blood cholesterol levels.

• Endometriosis—Estrogens may worsen endometriosis by causing growth of endometriosis implants.

• Fibroid tumors of the uterus—Estrogens may cause fibroid tumors to increase in size.

• Gallbladder disease or gallstones (or history of)—There is no clear evidence as to whether estrogens increase the risk of gallbladder disease or gallstones

• Jaundice (or history of during pregnancy)—Estrogens use may worsen or cause jaundice in these patients.

• Liver disease—Toxic drug effects may occur in patients with liver disease because the body is not able to get this medicine out of the bloodstream as it normally would.

• Porphyria—Estrogens can worsen porphyria.

Proper Use of This Medicine

For patients taking any of the androgen and estrogen products by mouth:

• Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered.


• Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.


• Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For esterified estrogens and methyltestosterone


• For oral dosage form (tablets):
  
  • For treatment of certain signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness:
    
    • Adults—0.625 to 2.5 mg of esterified estrogens and 1.25 to 5 mg of methyltestosterone once a day for twenty-one days. Stop the medicine for seven days, then repeat the twenty-one day cycle.
    
    
  
  

• For testosterone cypionate and estradiol cypionate


• For injection dosage form:
  
  • For treatment of certain signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness:
    
    • Adults—50 milligrams (mg) of testosterone cypionate and 2 mg of estradiol cypionate injected into a muscle once every four weeks.
    
    
  
  

• For testosterone enanthate and estradiol valerate


• For injection dosage form:
  
  • For treatment of certain signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness:
    
    • Adults—90 milligrams (mg) of testosterone enanthate and 4 mg of estradiol valerate injected into a muscle once every four weeks.
    
    
  
  

• For testosterone enanthate benzilic acid hydrazone, estradiol dienanthate, and estradiol benzoate


• For injection dosage form:
  
  • For treatment of bone loss (osteoporosis) or certain signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness:
    
    • Adults—150 milligrams (mg) of testosterone enanthate benzilic acid hydrazone, 7.5 mg of estradiol dienanthate, and 1 mg of estradiol benzoate injected into a muscle once every four to eight weeks or less.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have any questions about this, check with your doctor.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects . These visits will usually be every 6 to 12 months, but many doctors require them more often.

It is not yet known whether the use of estrogen increases the risk of breast cancer in women. Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. You should also have a mammogram (x-ray picture of the breasts) done if your doctor recommends it.

In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums

For diabetic patients:

• This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

If you think that you may have become pregnant, check with your doctor immediately. Continued use of this medicine during pregnancy may cause birth defects or future health problems in the child.

In studies with oral contraceptives (birth control pills) containing estrogens, cigarette smoking during the use of estrogens was shown to cause an increased risk of serious side effects affecting the heart or blood circulation, such as dangerous blood clots, heart attack, or stroke. The risk increased as the amount of smoking and the age of the smoker increased. Women aged 35 and over were at greatest risk when they smoked while using oral contraceptives containing estrogens. It is not known if this risk exists with the use of androgens and estrogens for symptoms of menopause. However, smoking may make estrogens less effective.

Do not give this medicine to anyone else. Your doctor has prescribed it specifically for you after studying your health record and the results of your physical examination. Androgens and estrogens may be dangerous for some people because of differences in their health and body chemistry.

Side Effects of This Medicine

Discuss these possible effects with your doctor:

Tumors of the liver, liver cancer, and peliosis hepatis (a form of liver disease) have occurred during long-term, high-dose therapy with androgens. Although these effects are rare, they can be very serious and may cause death.

When androgens are used in women, especially in high doses, male-like changes may occur, such as hoarseness or deepening of the voice, unnatural hair growth, or unusual hair loss. Most of these changes will go away if the medicine is stopped as soon as the changes are noticed. However, some changes, such as voice changes, may not go away.

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the uterus lining) in women after menopause. The risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than one year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.

It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Although some large studies show an increased risk, most studies and information gathered to date do not support this idea.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Uncontrolled jerky muscle movements


• vomiting of blood (with long-term use or high doses)

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Acne or oily skin (severe)


• breast pain or tenderness


• changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)


• enlarged clitoris


• enlargement or decrease in size of breasts


• hoarseness or deepening of voice


• swelling of feet or lower legs


• unnatural hair growth


• unusual hair loss


• weight gain (rapid)

Less common or rare

• Confusion


• dizziness


• flushing or redness of skin


• headaches (frequent or continuing)


• hives (especially at place of injection)


• shortness of breath (unexplained)


• skin rash, hives, or itching


• unusual bleeding


• unusual tiredness or drowsiness

With long-term use or high doses

• Black, tarry, or light-colored stools


• dark-colored urine


• general feeling of discomfort or illness (continuing)


• hives (frequent or continuing)


• loss of appetite (continuing)


• lump in, or discharge from breast


• nausea (severe)


• pain, swelling, or tenderness in stomach or upper abdomen (continuing)


• purple- or red-colored spots on body or inside the mouth or nose


• sore throat or fever (continuing)


• unpleasant breath odor (continuing)


• vomiting (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bloating of abdomen or stomach


• cramps of abdomen or stomach


• loss of appetite (temporary)


• nausea (mild)


• stomach pain (mild)


• unusual increase in sexual desire


• vomiting (mild)

Less common

Also, many women who are taking a progestin (another type of female hormone) with this medicine will begin to have monthly vaginal bleeding again, similar to menstrual periods. This effect will continue for as long as this medicine is used. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

• Constipation


• diarrhea (mild)


• dizziness (mild)


• headaches (mild)


• infection, redness, pain, or other irritation at place of injection


• migraine headaches


• problems in wearing contact lenses


• trouble in sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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